FDA Issues Draft Guidance on Postmarketing Adverse Event Reporting

Recently, the Food and Drug Administration issued a Draft Guidance entitled, Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without An Approved Application. The Dietary Supplement and Nonprescription Drug Consumer Protection Act (the “Act”), which amended the Federal Food, Drug, and Cosmetic Act (“FDCA”), required the addition of safety reporting requirements for over-the-counter drug products that are marketed without an approved marketing application, such as those sold pursuant to an OTC drug monograph. Before the enactment of the Act, only those OTC drugs marketed with an approved application were subject to mandatory postmarketing safety reporting requirements. A copy of the document can be accessed here.

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